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Green Guard Cough and Cold Relief

Medically reviewed on February 24, 2017

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 15mg, GUAIFENESIN 200mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Unifirst First Aid Corporation
NDC Code: 47682-006

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Green Guard Cough and Cold Relief

Drug Facts

Active ingredients (in each tablet)

Acetaminophen                                        325 mg

Dextromethorphan Hydrobromide            15mg

Guaifenesin                                                200mg

Phenylephrine Hydrochloride                       5mg

Purposes

Pain reliever/ fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

Temporarily relieves these cold symptoms

  • cough
  • sore throat
  • minor aches and pains
  • headache
  • nasal congestion
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Temporarily reduces fever.

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert:

Acetaminophen may cause severe skin reactions. Symptoms may include:

■ skin reddening

■ blisters

■ rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning:

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

Do not use
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you have ever had an allergic reaction to this product or any of its ingredients
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • chronic cough that lasts as occurs with smoking, asthma, chronic bronchitis or emphysema

Ask a doctor or pharmacist before use if you are
  • taking the blood thinning drug warfarin

When using this product
  • do not use more than directed

Stop use and ask a doctor if
  • new symptoms occur
  • redness or swelling is present
  • pain or nasal congestion gets worse or lasts for more than 7 days
  • fever gets worse or lasts for more than 3 days
  • you get nervous, dizzy or sleepless
  • cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Adults and children: (12 years and older)

Take 2 tablets with water every 6- 8 hours as needed. Do not take more than 8 tablets in 24 hours.

Children under 12 years:

Do not give to children under 12 years of age.

Other information
  • store at room temperature 59°-86°F (15°-30°C)
  • avoid excessive heat and humidity
  • tamper evident sealed packets
  • do not use any opened or torn packets

Inactive ingredients

maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate, starch, stearic acid

Questions or comments? 1-800-869-6970

Green Guard Cough and Cold Relief Label

Cough and Cold 2 relief
Pain reliever/Fever reducer
Multi-Symptom Relief
Green Guard®
Pull To Open

Tire Para Abrir
Tabletas para el alivio la y el resfriado

Acetaminophen/Acetamonofeno 325mg
Dextromethorphan HBr/Hidrobromuro de dextrometorfano 15mg
Guaifenesin/Guaifenesina 200mg
Phenylephrine HCl/Hidrocloruro de fenilefrina 5mg
125 Packets of 2 Tablets
250 Tablets
Order #2217
Distributed by Green Guard®, St Louis, MO 63045

GREEN GUARD COUGH AND COLD RELIEF 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-006
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
MALTODEXTRIN 
POVIDONE 
SODIUM STARCH GLYCOLATE TYPE A CORN 
STARCH, CORN 
STEARIC ACID 
Product Characteristics
Colorwhite (white) Scoreno score
ShapeROUND (ROUND) Size12mm
FlavorImprint CodeFR;12
Contains    
Packaging
#Item CodePackage Description
1NDC:47682-006-3350 PACKET in 1 BOX, UNIT-DOSE
1NDC:47682-006-992 TABLET in 1 PACKET
2NDC:47682-006-48125 PACKET in 1 BOX, UNIT-DOSE
2NDC:47682-006-992 TABLET in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/30/2008
Labeler - Unifirst First Aid Corporation (832947092)
Establishment
NameAddressID/FEIOperations
ULtratab Laboratories, Inc.151051757manufacture(47682-006)

 
Unifirst First Aid Corporation

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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